Zidovudine

Which March day?

FDA’s current approval record dates marketing approval of the 100 mg oral Retrovir capsule — zidovudine, also called AZT — to 19 March 1987. It was the first FDA-approved antiretroviral drug for AIDS.

A contemporary FDA talk paper issued on 9 April 1987 instead said the drug became approved on 20 March, which is where many historical accounts and this listing get their date. The discrepancy sits inside the agency’s own paperwork.

A much narrower label than “HIV/AIDS”

The initial indication did not cover everyone with HIV. It applied to certain adults with symptomatic HIV infection — AIDS or advanced AIDS-related complex — who had a confirmed history of Pneumocystis pneumonia or a pre-treatment CD4 count below 200 per cubic millimetre.

It was the first approved antiretroviral, not a cure, and not the multidrug combination therapy that later transformed long-term HIV management.

107 days, and nineteen deaths

The pivotal randomized placebo-controlled trial enrolled 282 patients with AIDS or advanced ARC and was halted early: one death among 145 AZT recipients against 19 among 137 placebo recipients. Burroughs Wellcome submitted its application in December 1986.

FDA completed the review in 107 days, described at the time as an agency record — an unusually fast priority review that predated FDA’s formal Accelerated Approval regulations of 1992.

The trial established a striking short-term benefit in advanced disease. It did not settle long-term efficacy, optimal dosing or toxicity, and serious bone-marrow suppression was already a recognized concern.